Clinical trial · Interventional
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial
NCT00330382CI-TRIAL-00016401completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lip and Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oral Leukoplakia | — | UNRESOLVED | — |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bowman-Birk inhibitor concentrate | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Bowman-Birk inhibitor concentrate)
- description
- Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
- interventionNames
- Drug: Bowman-Birk inhibitor concentrate
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive oral placebo twice daily for 6 months
- interventionNames
- Other: placebo
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Relative Percent Change in Total Lesion Area After 6 Months on Study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and clinically confirmed oral leukoplakia and/or erythroplakia * Bidimensionally measurable disease (≥ 100 mm\^2 for total area of all lesions) after biopsy * No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine * At least 6 months since prior Bowman-Birk inhibitor concentrate * At least 6 months since prior participation in another randomized clinical trail * At least 3 months since prior systemic steroids or topical oral steroid preparations * Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders allowed * More than 6 months since prior beta carotene capsules * At least 2 years since prior retinoid or other beta carotene therapy, including \> 25,000 IU of vitamin A for any reason * Up to 2 multivitamins per day allowed
References
Publications (4)
- BACKGROUNDMeyskens FL. Development of Bowman-Birk inhibitor for chemoprevention of oral head and neck cancer. Ann N Y Acad Sci. 2001 Dec;952:116-23. doi: 10.1111/j.1749-6632.2001.tb02732.x. PMID 11795430
- BACKGROUNDMeyskens FL Jr. Development of difluoromethyl-ornithine and Bowman-Birk inhibitor as chemopreventive agents by assessment of relevant biomarker modulation: some lessons learned. IARC Sci Publ. 2001;154:49-55. PMID 11220668
- RESULTArmstrong WB, Taylor TH, Kennedy AR, Melrose RJ, Messadi DV, Gu M, Le AD, Perloff M, Civantos F, Goodwin WJ, Wirth LJ, Kerr AR, Meyskens FL Jr. Bowman birk inhibitor concentrate and oral leukoplakia: a randomized phase IIb trial. Cancer Prev Res (Phila). 2013 May;6(5):410-8. doi: 10.1158/1940-6207.CAPR-13-0004. PMID 23639862
- RESULTArmstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007. PMID 14520092